- Histological or cytological diagnosis of advanced/metastatic solid tumor malignancy
which has progressed on standard therapy or for which no standard therapy is
available.
- Measurable disease per RECIST v1.1.
- Adequate bone marrow, renal and liver functioning
- CNS primary malignancies, active seizure disorder or spinal cord compression, or
carcinomatous meningitis.
- History of any of the following toxicities associated with a prior immunotherapy:
- Grade 3 immune mediated adverse event that was considered related to previous
immunotherapy and required immune suppressive therapy;
- Grade 2 hepatic function related adverse event that persisted more than 1 week,
was considered related to immunotherapy, or required treatment discontinuation or
immunosuppressive therapy
- Any of the following within the 12 months prior to registration: myocardial
infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic
congestive heart failure, cerebrovascular accident or transient ischemic attack and 6
months for deep vein thrombosis or pulmonary embolism.
- History of or known presence of extensive, disseminated/bilateral or Grade 3 or 4
interstitial fibrosis or interstitial lung disease, including a history of
pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung
disease, obliterative bronchiolitis, or pulmonary fibrosis, but not including a
history of prior radiation pneumonitis. Patients with clinically significant lung
disease requiring oxygen therapy (eg, COPD).